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Microbiome modulator improved glucose tolerance in patients with diabetes
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CHICAGO — An experimental microbiome modulator, NM504, appears to improve glucose tolerance when altering microbial populations in the gastrointestinal tract, according to research presented at the joint meeting of the International Congress of Endocrinology and the Endocrine Society.
In a pilot study of the drug, Mark Louis Heiman, PhD, chief scientific officer for MicroBiome Therapeutics, and colleagues found NM504 — the first in a class of gastrointestinal (GI) microbiome modulators — to be safe and effective in patients with pre- and type 2 diabetes.
“We look at food, particularly a meal, as a dose to the ecosystem of the intestinal tract,” Heiman said during his presentation. “Some of us dose three times a day. People with obesity and type 2 diabetes may overdose three times a day.”
Because these ‘overdoses’ saturate the body’s digestive mechanisms, Heiman said more partially digested food is getting into the GI microbiome and causing imbalances. NM504, which is comprised of bioactive ingredients isolated and purified from foods, is designed to shift GI microorganisms. The drug ingredients include inulin (from the agave plant), beta glucan (from oat) and polyphenolic antioxidant compounds (from blueberries).
The scientists recruited 28 participants with prediabetes or diabetes for a 4-week double-blind, randomized, placebo-controlled trial. They were evenly divided and assigned to NM504 treatment two times daily, prior to either breakfast or lunch and prior to dinner. Oral glucose tolerance tests (OGTT) were given at baseline and the end of the study; a meal tolerance test was also administered.
Compared with placebo, the therapeutic improved serum glucose levels at both 120 and 180 minutes during OGTT (P<.05) and was well-tolerated, Heiman said; insulin levels were similar between groups. NM504 also increased insulin sensitivity during the tests.
Improved glucose tolerance correlated with decreased circulating levels of alkaline phosphatase (P=.06), high sensitivity C-reactive protein (P=.012) and total cholesterol (P=.01).
Treatment with NM504 also decreased patients’ desire to eat (P=.03), increased stool immunoglobulin A levels (P=.03) and decreased stool pH (P=.03). Patients reported mild increase in flatulence.
Researchers attributed the drug’s effects to absorption of glucose and bile salts, but indicated that other mechanisms of action could include maintaining the mucosal barrier, exposing the lumen to more antioxidants or higher viscosity levels of the lumen. They noted changes in microbiota abundance and production of short chain fatty acid, but there were no significant differences.
Trends toward increased GLP-I levels and decreased ocatanoyl ghrelin levels were observed in response to a meal tolerance test at week 3.
“We believe that over the next 10 years, there will be many more innovative signaling molecules produced by these microorganisms that will help regulate the immune system and the brain,” Heiman said. “That will lead to new treatments and new therapies.” — by Allegra Tiver
For More Information: Heiman ML. Abstract OR40-5. Presented at: The joint meeting of the International Congress of Endocrinology and the Endocrine Society; June 21-24, 2014; Chicago.
Disclosures: Heiman is the Chief Scientific Officer for MicroBiome Therapeutics.